OBI Pharma announced the FDA has approved its investigational new drug application for OBI-992, allowing the start of a phase 1/2 clinical trial to evaluate their novel TROP2-targeted antibody-drug conjugate for cancer treatment.
Belief BioMed Group announced the start of patient treatment in a major BBM-H803 study. This gene therapy aims to treat hemophilia A and is independently developed by Belief BioMed.
Sciwind Biosciences Reveals Encouraging Preliminary Outcomes from a Final-Stage Study of Ecnoglutide (XW003), an Extended-Duration GLP-1 Mimetic with Selective cAMP Pathway Activation, in Chinese Adults Suffering from Type 2 Diabetes.
Coherus BioSciences, Inc. has recently declared that their product, LOQTORZI™ (toripalimab-tpzi), can now be acquired from certain specialty distribution channels within the U.S. market.
When submitting an ANDA, generic drug manufacturers need to submit one of the following four statements in accordance with the provisions of the Orange Book.
Atom Bioscience, a biotech company specializing in innovative therapies for inflammation and metabolic diseases, announced FDA approval for the Phase 1 trial of its new drug, ABP-745.
Ubix Therapeutics Granted Green Light from FDA for Initial Clinical Trial of Oral Drug UBX-303-1, a BTK Inhibitor Aimed at Treating Resistant B-Cell Cancers.
Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements.